In preparation for the forthcoming NIH COI (Conflict of Interest) review requirements, and to comply with standards set by the Association for the Accreditation of Human Research Protections Programs (AAHRPP), on August 29th, 2011 we will be implementing the following change to all new eResearch IRB applications and future amendments to approved applications.

Previously, only PIs, Co-Is, and Faculty Advisors were required to accept their roles and answer conflict of interest questions. Beginning August 29th, additional members of the study team, including Study Coordinators, Consultants, and others, will now be required to accept their role and answer a set of short, general questions intended to identify individuals with a potential COI. Only those individuals who are identified as having a possible COI based on their responses to these questions will be contacted by the appropriate COI review committee to answer additional, more detailed questions.

Beginning August 29th, the study team Staff role will be replaced by two new roles, identifying specific functions as follows:

Research staff - individuals who are involved in the design, conduct, and reporting of research. These individuals will be required to accept their role and answer the COI questions prior to IRB submission of the IRB application.

Administrative staff - individuals who are NOT involved in the design, conduct, or reporting of research (e.g., unit administrators). These individuals will NOT be required to accept their role or complete the COI questions.

In addition to the roles described above, we have added a new role, Biostatistician, for study personnel performing the functions of a separate role for biostatistician/statistician.s These individuals will be required to accept their role and answer the COI questions prior to IRB submission of the IRB application.

For new applications and amendments in pre-submission at the time this update is implemented, all members of the study team, except administrative staff, will now be prompted and required to accept their role and answer the COI questions.

For new applications and amendments that are under review at the time that this update is implemented, your submission will be returned to you so that any newly impacted study team members may accept their roles and answer the COI questions.

If you have questions about how to take the appropriate steps to fulfill this requirement,
please contact the IRB to which you have or will be submitting your application. If you have questions about the University's COI policy, NIH regulations, or AAHRPP standards, please contact Assistant Vice President for Research Lois Brako (lbrako@umich.edu).

New Conflict of Interest Questions (coming August 29, 2011)

Conflict of Interest:

C1 *Do you, your spouse, domestic partner, or dependents have any outside interests or relationships to companies or entities related to this research that the IRB should consider?

Examples of outside interests include, but are not limited to the following:

receiving compensation whose value could be affected by the study outcome

IN THE AGGREGATE, expecting to receive compensation from the sponsor of the research of $10,000 or greater in the next year

having a proprietary interest in the sponsor of the research or a product tested by this research including but not limited to, a patent, trademark, copyright, or licensing agreement, or the right to receive royalties from product commercialization

individually or collectively, having an ownership interest (equity or stock options) in the sponsor of the research or product being tested whose value cannot be readily determined through reference to public prices

individually or collectively, having an ownership interest (equity or stock options) in a company or product whose value could be affected by the study outcome

IN THE AGGREGATE, having an ownership interest (equity or stock options) in the sponsor of the research that exceeds $10,000 or 1% when the sponsor is a publicly traded entity

receiving significant payments of other sorts with an aggregate value of $10,000 or more (or payment of ANY amount to medical school or hospital employees) made directly by the sponsor of this research for unrestricted research or education, equipment, consultancy, or honorarium

holding a position of management or leadership in company or entity related to this research including, but not limited to, officer, director, or member of an advisory board.

providing consulting services or serve on a Speaker's Bureau, either paid or unpaid, to the financial or non-financial sponsor of this study

when the sponsor is a publicly traded entity, having any ownership interest (equity or stock options) in the sponsor

expecting to receive any loans, educational support, contributions of in-kind for equipment, or any other non-compensatory payment from the sponsor of the research in the next year

YesNo

If response to C1 is Yes, the study team member must respond to the following questions:

C2 Please provide a detailed description of the outside interest in the box below.

C2.1 Where have you submitted a disclosure of this outside interest?

Select one:

UM Medical School Conflict of Interest Committee (M-Inform)

UM OVPR Conflict of Interest Committee

School/College/Unit

Have not submitted disclosure

C2.2 Has a management plan been formalized?

YesNo

C2.2.1 If yes, attach the management plan here, as well as any other applicable conflict of interest documents.

C2.2.2 If no, describe the financial interest in sufficient detail to permit the COI Ancillary Committee and the IRB to determine if such involvement represents a potential conflict-of-interest and/or should be disclosed to potential research subjects in the informed consent form.